FDA.reportPublic FDA data

Marketlab, Inc

Primary DI
00817517025101
Brand
Marketlab, Inc
Company
MARKETLAB INC.
Model
10980
Device description
"Nylon Small Biopsy Bags - 2""W x 1.125""H - 200/pk"
Published
2023-02-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KETFilters, Cell Collection, Tissue Processing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KETFilters, Cell Collection, Tissue ProcessingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817517025101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817517025101008175170251018175170251010817517025101

GMDN Terms#

Term, Definition table
TermDefinition
Histology tissue cassette IVD, laboratory processing, single-useA small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a synthetic polymer container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
848917027
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817518026107MarketLab, Inc.108165-FSC-AEL2026-07-16
00817518026268MarketLab, Inc.1000442-FSC2026-07-16
00817518026275MarketLab, Inc.1000443-FSC2026-07-16
00817518024523MarketLab, Inc.1087812025-12-18
00817643023972Hopkins1380422024-02-02
00817517027938Marketlab-Clinton1387632024-02-02
00817517027945Marketlab-Clinton1387642024-02-02
00817517027952Marketlab-Clinton1387652024-02-02
00817517027969Marketlab-Clinton1387662024-02-02
00817517027976Marketlab-Clinton1387672024-02-02
00817517027983Marketlab-Clinton1387682024-02-02
00817517027990Marketlab-Clinton1387692024-02-02
00817517028003Marketlab-Clinton1387702024-02-02
00817517028072Marketlab-Clinton1387712024-02-02
00817517028089Marketlab-Clinton1387722024-02-02
00817517028096Marketlab-Clinton1387732024-02-02
00817517028102Marketlab-Clinton1387742024-02-02
00817517028119Marketlab-Clinton1387752024-02-02
00817517028126Marketlab-Clinton1387762024-02-02
00817517028133Marketlab-Clinton1387772024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410078PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410085PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410313PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410504PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410511PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
04260649292075cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292099cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292112cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292068cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292082cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292105cytoQ®SABEU GmbH & Co. KGKET2026-02-10
07898027900792CELLPRESERV KOLPLASTKolplast C IKET2023-11-29
00630094188508Bioseal Inc.BIOSEALKET2023-10-05
00630094188515Bioseal Inc.BIOSEALKET2023-10-05
00630094188607Bioseal Inc.BIOSEALKET2023-10-05
00630094887029Bioseal Inc.BIOSEALKET2023-10-05
00630094889054Bioseal Inc.BIOSEALKET2023-10-05
10630094188505Bioseal Inc.BIOSEALKET2023-10-05
10630094188512Bioseal Inc.BIOSEALKET2023-10-05
10630094188604Bioseal Inc.BIOSEALKET2023-10-05
10630094887026Bioseal Inc.BIOSEALKET2023-10-05
10630094889051Bioseal Inc.BIOSEALKET2023-10-05
00853778007005Double Cytology Funnel w/ White Card and CapsBiomedical Polymers, Inc.KET2023-08-21
00853778007135BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
00853778007142Single Cytology Funnel w/ Brown CardBiomedical Polymers, Inc.KET2023-08-21
00853778007159BMP Medical Metal Cytology ClipBiomedical Polymers, Inc.KET2023-08-21
20853778007009Double Cytology Funnel w/ White Card and CapsBiomedical Polymers, Inc.KET2023-08-21
10853778007132BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
10853778007149Single Cytology Funnel w/ Brown CardBiomedical Polymers, Inc.KET2023-08-21
10853778007156BMP Medical Metal Cytology ClipBiomedical Polymers, Inc.KET2023-08-21